Array withdraws product for skin cancer from FDA review

March 19, 2017

Array BioPharma Inc. (ARRY) today announced that it has withdrawn from the U.S. Food and Drug Administration’s (FDA) Division of Oncology Products 2 its new drug application (NDA) for binimetinib monotherapy for the treatment of NRAS-mutant melanoma, a rare, mutationally-driven subset of skin cancer.

This action was based on thorough discussions and communications with the FDA, including exploration of various paths to approval, and followed the late cycle review meeting held with the FDA on Friday, March 17, 2017. Based on feedback from the agency, Array concluded that the clinical benefit demonstrated in the Phase 3 NEMO clinical trial would not be found sufficient to support approval of the NRAS-mutant melanoma NDA.

Ongoing clinical trials for binimetinib will continue. This action will not impact the planned Phase 3 COLUMBUS trial NDA of binimetinib, in combination with encorafenib, for the treatment of BRAF-mutant melanoma, which remains on track for mid-2017.

About NRAS-Mutant MelanomaOf the estimated 10,000 annual cases of metastatic melanoma in the United States, activating NRAS mutations are present in approximately 20 percent of these patients. The presence of an NRAS mutation is a poor prognostic indicator for these patients, and treatment options for this population remain limited beyond immunotherapy.